a study evaluating the efficacy, safety, and pharmacokinetics of glofitamab in combination with rituximab plus ifosfamide, carboplatin etoposide phosphate in participants with relapsed/refractory transplant or car-t therapy eligible diffuse b-cell lymphoma

Conditions: Diffuse Large B-Cell Lymphoma (DLBCL)

Summary: the purpose of this study is to evaluate the preliminary efficacy, safety, and pharmacokinetics of glofitamab (glofit) in combination with rituximab plus ifosfamide, carboplatin, and etoposide (r-ice) in participants with relapsed or refractory (r/r) diffuse large b-cell lymphoma (dlbcl), who have failed one prior line of therapy incorporating an anti-cluster of differentiation (cd) 20 antibody (i.e., rituximab) and an anthracycline, and who are transplant or chimeric antigen receptor t-cell (car-t) therapy eligible, defined as being medically eligible for intensive platinum-based salvage therapy followed by autologous stem cell transplantation (asct) or for car-t therapy.


Eligibility criteria:
inclusion criteria: * life expectancy ≥ 12 weeks * histologically confirmed b-cell lymphoma * one line of prior systemic therapy including an anti-cd20 monoclonal antibody (i.e. rituximab) and an anthracycline * relapsed or refractory disease after first-line chemoimmunotherapy * eastern cooperative oncology group (ecog) performance status of 0 or 1 * participant must be a candidate for high-dose chemotherapy followed by asct or car-t therapy exclusion criteria: * treatment with more than one prior line of therapy for dlbcl * primary mediastinal b-cell lymphoma * prior treatment with glofitamab or other bispecific antibodies targeting both cd20 and cd3 * peripheral neuropathy assessed to be grade \> 1 according to national cancer institute common terminology criteria for adverse events (nci ctcae) v5.0 at enrollment * treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment * treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment * primary or secondary cns lymphoma at the time of enrollment or history of cns lymphoma * current or history of cns disease, such as stroke, epilepsy, cns vasculitis, or neurodegenerative disease * known or suspected history of hemophagocytic lymphohistiocytosis (hlh) * known history of progressive multifocal leukoencephalopathy * adverse events from prior anti-cancer therapy that have not resolved to grade 1 or better (with the exception of alopecia and anorexia, or as otherwise permitted by inclusion criteria) * prior solid organ transplantation * prior allogeneic stem cell transplant * prior asct for lymphoma * prior autologous stem cell transplant for any indication other than lymphoma, within 5 years from the start of study treatment * active autoimmune disease requiring treatment * prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), within 4 weeks prior to first dose of study treatment * ongoing corticosteroid use \> 30 mg/day of prednisone or equivalent. participants who received corticosteroid treatment with ≤ 30 mg/day of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration prior to cycle 1 day 1. participants may have received a brief (≤ 7 days) course of systemic steroids (≤ 100 mg prednisone equivalent per day) prior to initiation of study therapy for control of lymphoma-related symptoms * recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis * clinically significant history of cirrhotic liver disease